Amlodipine Besylate

Product NDC: 64679-422
11-digit product format: 646790422
Labeler code: 64679
Product ID: 64679-422_ca52537d-f250-4092-9033-960674a43410
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: ANDA078500
Marketing category: ANDA
Marketing start: 2007-09-06
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-422		D	Discontinued by firm	2026-10-05
excluded package	package	64679-422	64679-422-01	D	Discontinued by firm	2026-10-05
excluded package	package	64679-422	64679-422-02	D	Discontinued by firm	2026-10-05
excluded package	package	64679-422	64679-422-03	D	Discontinued by firm	2026-10-05
excluded package	package	64679-422	64679-422-04	D	Discontinued by firm	2026-10-05
excluded package	package	64679-422	64679-422-05	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 126 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-422-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-422-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-422-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-422-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-422-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-422-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-422-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-422-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-422-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-422-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-422-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-422-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-422-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-422-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-422-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-422-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-422-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-422-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-422-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-422-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-422-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-422-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-422-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-422-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-422-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-422-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-422-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-422-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-422-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-422-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-422-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-422-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-422-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-422-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-422-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-422-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-422-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-422-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-422-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-422-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-422-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-422-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-422-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-422-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-422-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-422-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-422-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-422-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-422-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-422-01	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078500-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06
A078500-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06
A078500-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078500-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078500-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078500-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-09-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078500-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078500-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078500-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A078500-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078500-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078500-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078500-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078500-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078500-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078500-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078500-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078500-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078500-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078500-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078500-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078500-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078500-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078500-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-422-01	2024-10-24	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-02	2024-10-24	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-03	2024-10-24	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-04	2024-10-24	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-05	2024-10-24	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-01	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-02	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-03	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-04	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
64679-422-05	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-422-01	EA - Each	64679-422	f0146258-60d2-4f79-a3cc-a27504d0b4f8	1	2012-07-24
64679-422-02	EA - Each	64679-422	b5f1a951-02ac-44a4-8d09-d5212118edec	1	2012-07-24
64679-422-03	EA - Each	64679-422	bba75f38-9dc9-499c-8b7f-235d9e962490	1	2022-04-06
64679-422-04	EA - Each	64679-422	836bedb9-22fb-42cf-bcb1-8eb41007aec6	1	2022-04-06
64679-422-05	EA - Each	64679-422	26c0342f-7637-4166-b9a1-c982d928925d	1	2022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [WOCKHARDT USA LLC.]	2
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [STAT RX USA LLC]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [STAT RX USA LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	c32059ed-73cd-4a2c-9690-276e7068041e	1
197361	amlodipine 5 MG Oral Tablet	SCD	c32059ed-73cd-4a2c-9690-276e7068041e	1
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	c32059ed-73cd-4a2c-9690-276e7068041e	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	Wockhardt USA LLC. \| Wockhardt Limited	2018-04-19	HUMAN PRESCRIPTION DRUG LABEL	4
Amlodipine Besylate Tablets Rx only	STAT RX USA LLC	2010-03-12	HUMAN PRESCRIPTION DRUG LABEL	1